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1.
Scientific and Regulatory Policy Committee Points to Consider: Sampling, Processing, Evaluation, Interpretation, and Reporting of Test Article-Related Ganglion Pathology for Nonclinical Toxicity Studies.
Toxicol Pathol
; 51(4): 176-204, 2023 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-37489508
2.
Scientific and Regulatory Policy Committee Technical Review: Biology and Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing.
Toxicol Pathol
; 51(5): 278-305, 2023 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-38047294
3.
Special Issue on the Pathobiology of Laboratory Nonhuman Primates: A Review of Species, Substrain, Geographical Origin, Age, and Modality-Related Factors.
Toxicol Pathol
; 50(5): 548-551, 2022 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-35768952
4.
Antisense Oligonucleotide-Related Macrovesicular Vacuolation of Hippocampal Neurons in Nonhuman Primates.
Toxicol Pathol
; 50(2): 197-210, 2022 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-35042440
5.
Perspective on Adversity in Toxicology Evaluations.
Toxicol Pathol
; 49(2): 408-410, 2021 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-32807041
6.
The Application, Challenges, and Advancement Toward Regulatory Acceptance of Digital Toxicologic Pathology: Results of the 7th ESTP International Expert Workshop (September 20-21, 2019).
Toxicol Pathol
; 49(4): 720-737, 2021 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-33297858
7.
Comparison of the Class Effects of Antisense Oligonucleotides in CByB6F1-Tg(HRAS)2Jic and CD-1 Mice.
Toxicol Pathol
; 47(1): 82-92, 2019 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30585133
8.
Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics.
Toxicol Pathol
; 43(7): 915-34, 2015 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25722122
9.
Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides.
Toxicol Pathol
; 43(7): 935-44, 2015 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25717082
10.
Nonlesions, misdiagnoses, missed diagnoses, and other interpretive challenges in fish histopathology studies: a guide for investigators, authors, reviewers, and readers.
Toxicol Pathol
; 43(3): 297-325, 2015 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-25112278
11.
Safety and Tolerability of GalNAc3-Conjugated Antisense Drugs Compared to the Same-Sequence 2'-O-Methoxyethyl-Modified Antisense Drugs: Results from an Integrated Assessment of Phase 1 Clinical Trial Data.
Nucleic Acid Ther
; 34(1): 18-25, 2024 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-38227794
12.
Calcium lignosulphonate: re-evaluation of relevant endpoints to re-confirm validity and NOAEL of a 90-day feeding study in rats.
Regul Toxicol Pharmacol
; 66(3): 286-99, 2013 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-23665266
13.
Complement C3d/C4d Deposition on Platelets Correlates with 2'-O-Methoxyethyl Antisense Oligonucleotide-Induced Thrombocytopenia in Monkeys.
Nucleic Acid Ther
; 33(3): 209-225, 2023 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-37093125
14.
Industry-contract research organization pathology interactions: a perspective of contract research organizations in producing the best quality pathology report.
Toxicol Pathol
; 39(2): 422-8, 2011 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-21270423
15.
Hazard identification and consumer safety characterization for trans-1-chloro-3,3,3-trifluoropropene (trans-1233zd).
Toxicol Lett
; 332: 181-191, 2020 Oct 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-32473956
16.
Underlying Immune Disorder May Predispose Some Transthyretin Amyloidosis Subjects to Inotersen-Mediated Thrombocytopenia.
Nucleic Acid Ther
; 30(2): 94-103, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-32043907
17.
Antisense oligonucleotide treatment ameliorates IFN-γ-induced proteinuria in APOL1-transgenic mice.
JCI Insight
; 4(12)2019 06 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-31217349
18.
Regulatory forum opinion piece*: pathology peer review--to lock or not to lock, is that really the question?
Toxicol Pathol
; 41(7): 1051-2, 2013.
Artículo
en Inglés
| MEDLINE | ID: mdl-23960166
19.
Predictivity of animal studies for human injection site reactions with parenteral drug products.
Exp Toxicol Pathol
; 60(4-5): 323-7, 2008 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-18513931
20.
Blood Pressure Lowering and Safety Improvements With Liver Angiotensinogen Inhibition in Models of Hypertension and Kidney Injury.
Hypertension
; 70(3): 566-576, 2017 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-28716988